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A Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Participants With Schizophrenia and Schizoaffective Disorder

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Roche

Status and phase

Completed
Phase 1

Conditions

Schizophrenia

Treatments

Drug: RO4917838
Drug: Standard Antipsychotic Therapy
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01116830
BP22445

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams [mg] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.

Enrollment

29 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of schizophrenia or schizoaffective disorder (based on screening tests)
  • Medically stable for 1 month and psychiatrically stable without symptom exacerbation for 6 weeks prior to baseline
  • On stable treatment with a maximum of 2 antipsychotics

Exclusion criteria

  • Change in regimen for any psychotropic or sleep medication within 1 month
  • Treatment with more than (>) 1 mood stabilizer or antidepressant
  • Use of clozapine within 2 months
  • Bipolar disorder, or more than mild anxiety disorder

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

29 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Standard Antipsychotic Therapy
Drug: Placebo
RO4917838
Experimental group
Treatment:
Drug: RO4917838
Drug: Standard Antipsychotic Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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